NEW YORK – Gilead Sciences has garnered fresh data on the activity of Trodelvy (sacituzumab govitecan) in lung cancer and will share detailed readouts from several trials at the American Society of Clinical Oncology's annual meeting in June.
During a call Thursday to discuss the company's first quarter financial performance, Gilead Chief Medical Officer Merdad Parsey said the company will report data at the meeting from the Phase III EVOKE-01 and Phase II EVOKE-02 trials. In EVOKE-01, researchers are assessing Trodelvy's activity in an all-comer non-small cell lung cancer population, and in EVOKE-02, they are testing Trodelvy plus Merck's checkpoint inhibitor Keytruda (pembrolizumab) in the first-line NSCLC setting in patients with a PD-L1 tumor proportion score greater than 50 percent.
Parsey noted that data from EVOKE-01 cannot be disclosed yet, but it is encouraging. "The full dataset does motivate us to go forward in lung cancer and with discussions with regulators," Parsey said. "The unmet need in this population is great, and the data give us options including discussions with health authorities and conducting follow-up trials."
At present, the antibody-drug conjugate Trodelvy is approved in the US for urothelial cancer and hormone receptor-positive, HER2-negative, and triple-negative breast cancer. In Q1, the drug recorded $309 million in Q1 sales compared to $222 million in the same period last year, a 39 percent increase.
"In second-line metastatic triple-negative breast cancer, Trodelvy remains the leading regimen with approximately one-third share of the US [market]," Gilead Chief Commercial Officer Johanna Mercier said on the call. "In the pretreated HR-positive, HER2-negative metastatic breast cancer setting, Trodelvy has demonstrated continued adoption, most notably in the IHC 0 setting."
During Q1 2024, the Foster City, California-based firm brought in $6.69 billion in total revenue, a 5 percent increase from $6.35 billion in Q1 2023, and above analysts' average revenue expectation of $5.92 billion. Gilead's oncology products, including Trodelvy and its two autologous CAR T-cell therapies Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel), generated $789 million in Q1 2024, an 18 percent increase from $670 million in the year-ago quarter.
Worldwide sales of Yescarta, a treatment for certain lymphomas, increased 6 percent to $380 million from $359 million a year ago. Sales of Tecartus, Gilead's other lymphoma cell therapy, grew 12 percent to $100 million from $89 million a year ago.
Mercier noted that the firm is working to expand patients' access to Yescarta and Tecartus. "In the US, we see opportunity for growth through expanding the number of authorized treatment centers and affiliated satellites, while also driving increased referrals from the community setting," she said, adding that Gilead partnered with community oncology network Tennessee Oncology in the first quarter to bring these cell therapies to community clinics.
"We've identified many critical learnings on how we can partner effectively with community oncology practices for cell therapy, and we will continue to refine this blueprint so that we become more efficient at onboarding new centers over time," Mercier said. "We expect to start seeing the impact from this initiative towards the end of 2024."
Later this year, Gilead expects to report data on its investigational CAR T-cell therapy, anitocabtagene autoleucel (anito-cel), from a Phase II trial in multiple myeloma. If Gilead is able to bring anito-cel to market in this setting, it will expand its cell therapy franchise beyond lymphomas, Parsey said.
In Q1 2024, Gilead posted a net loss attributable to the company of $4.17 billion, or $3.34 per share, compared to net income attributable to the company of $1.01 billion, or $.80 per share, in Q1 2023. The firm's adjusted loss per share was $1.32, less than the Wall Street consensus estimate of $1.39 loss per share.
As stated previously, the firm is still expecting between $27.1 billion and $27.5 billion in total product sales in 2024. However, the company updated its diluted EPS to a range of $.10 to $.50 from a previous range of $5.15 to $5.55, and adjusted diluted EPS to a range of $3.45 to $3.85 from a previous range of $6.85 to $7.25.
As of March 31, Gilead had $4.72 billion in cash, cash equivalents, and marketable debt securities.